{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Innsbruck",
      "state": "N/A",
      "country": "Austria",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81683",
      "recalling_firm": "MED-EL Elektromedizinische Gereate, Gmbh",
      "address_1": "Furstenweg 77a",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of  California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.",
      "recall_number": "Z-2138-2019",
      "product_description": "MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.",
      "product_quantity": "1 device",
      "reason_for_recall": "Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.",
      "recall_initiation_date": "20181016",
      "center_classification_date": "20190802",
      "termination_date": "20200522",
      "report_date": "20190814",
      "code_info": "Serial Number 202001"
    }
  ]
}